Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Mesh, Surgical
510(k) Number K896946
Device Name COATED NOVAFIL, POLYBUTESTER, MESH
Applicant
American Cyanamid Co.
One Casper St.
Danbury,  CT  06810
Applicant Contact B. I PARZUCHOWSKI
Correspondent
American Cyanamid Co.
One Casper St.
Danbury,  CT  06810
Correspondent Contact B. I PARZUCHOWSKI
Regulation Number878.3300
Classification Product Code
FTM  
Date Received12/13/1989
Decision Date 05/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-